CA2462905C - Method for the preparation of a pharmaceutical composition comprising 5-aminosalicyclic acid for use in treatment of ulcerative colitis and crohn's disease - Google Patents

Method for the preparation of a pharmaceutical composition comprising 5-aminosalicyclic acid for use in treatment of ulcerative colitis and crohn's disease Download PDF

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Publication number
CA2462905C
CA2462905C CA2462905A CA2462905A CA2462905C CA 2462905 C CA2462905 C CA 2462905C CA 2462905 A CA2462905 A CA 2462905A CA 2462905 A CA2462905 A CA 2462905A CA 2462905 C CA2462905 C CA 2462905C
Authority
CA
Canada
Prior art keywords
granules
solvent
asa
tablets
binder
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA2462905A
Other languages
English (en)
French (fr)
Other versions
CA2462905A1 (en
Inventor
Svenn Kluever Jepsen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ferring BV
Original Assignee
Ferring BV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ferring BV filed Critical Ferring BV
Publication of CA2462905A1 publication Critical patent/CA2462905A1/en
Application granted granted Critical
Publication of CA2462905C publication Critical patent/CA2462905C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA2462905A 2001-10-15 2001-10-15 Method for the preparation of a pharmaceutical composition comprising 5-aminosalicyclic acid for use in treatment of ulcerative colitis and crohn's disease Expired - Lifetime CA2462905C (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/DK2001/000677 WO2003032952A1 (en) 2001-10-15 2001-10-15 Method for the preparation of a pharmaceutical composition comprising 5-aminosalicyclic acid for use in treatment of ulcerative colitis and crohn's disease

Publications (2)

Publication Number Publication Date
CA2462905A1 CA2462905A1 (en) 2003-04-24
CA2462905C true CA2462905C (en) 2011-04-12

Family

ID=8149447

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2462905A Expired - Lifetime CA2462905C (en) 2001-10-15 2001-10-15 Method for the preparation of a pharmaceutical composition comprising 5-aminosalicyclic acid for use in treatment of ulcerative colitis and crohn's disease

Country Status (15)

Country Link
EP (1) EP1441700B1 (pt)
JP (1) JP4726414B2 (pt)
KR (1) KR100859358B1 (pt)
CN (1) CN100506234C (pt)
AT (1) ATE371441T1 (pt)
CA (1) CA2462905C (pt)
DE (1) DE60130270T2 (pt)
DK (1) DK1441700T3 (pt)
ES (1) ES2288999T3 (pt)
HK (1) HK1068282A1 (pt)
IL (2) IL161193A0 (pt)
MX (1) MXPA04003506A (pt)
NO (1) NO335042B1 (pt)
PT (1) PT1441700E (pt)
WO (1) WO2003032952A1 (pt)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070059368A1 (en) * 2005-05-31 2007-03-15 Cherukuri S R Modified release formulations of anti-irritability drugs
JP2007523664A (ja) * 2003-04-23 2007-08-23 フェリング ベスローテン フェンノートシャップ 医薬組成物用サシェ
EP1470819A1 (en) * 2003-04-23 2004-10-27 Ferring B.V. High drug load mesalazine sachet
EP1547601A1 (en) * 2003-12-23 2005-06-29 Ferring B.V. Coating method
KR20080085924A (ko) * 2004-09-01 2008-09-24 더 프록터 앤드 갬블 캄파니 5-아미노-2-하이드록시벤조산 및 환원당을 함유하는 조성물
GB0909680D0 (en) 2009-06-05 2009-07-22 Euro Celtique Sa Dosage form
EP2340812A1 (en) * 2009-12-18 2011-07-06 Ferring International Center S.A. Granules for pharmaceutical preparations, methods and apparatus for their production
DK2614045T3 (en) * 2010-09-10 2016-02-08 Pharmazell Gmbh Process for Preparation of Crystalline 5-Aminosalicylic Acid
US10071058B2 (en) * 2012-03-07 2018-09-11 Santarus, Inc. Controlled-release solid dosage forms of mesalamine
CN103622974B (zh) * 2013-12-05 2016-04-20 武汉武药科技有限公司 一种含美沙拉嗪和n-乙酰半胱氨酸的复方栓剂及其制备方法
WO2015193788A1 (en) * 2014-06-16 2015-12-23 Valpharma International S.P.A. Formulation for oral administration containing mesalazine
ITUA20162293A1 (it) * 2016-04-05 2017-10-05 Sofar Spa Processo per formulazioni solide di mesalazina
JP2017189121A (ja) * 2016-04-11 2017-10-19 国立大学法人旭川医科大学 抗ＴＮＦα抗体適応疾患の治療における抗ＴＮＦα抗体投与時反応の発症リスクを判定する方法、並びに該判定用オリゴヌクレオチドキット

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS57500432A (pt) * 1980-03-20 1982-03-11
JPH0334928A (ja) * 1989-06-29 1991-02-14 Teikoku Seiyaku Kk 潰瘍性大腸炎およびクローン病治療用経口投与製剤
DK0871434T4 (da) * 1995-12-21 2008-04-07 Ferring Farma Lab Oralt farmaceutisk sammensætning med modificeret frigivelse indeholdende 5-ASA og fremgangsmåde til behandling af tarmsygdomme
IT1303753B1 (it) * 1998-11-13 2001-02-23 Ct Lab Farm Srl Composizioni farmaceutiche somministrabili per via orale contenentiun rivestimento gastroresistente a base di polimeri acrilici.
IT1318625B1 (it) * 2000-07-14 2003-08-27 Roberto Valducci Formulazioni farmaceutiche solide orali a rilascio multifasicoph-dipendente.

Also Published As

Publication number Publication date
JP2005509619A (ja) 2005-04-14
JP4726414B2 (ja) 2011-07-20
DE60130270D1 (de) 2007-10-11
DE60130270T2 (de) 2008-05-29
ATE371441T1 (de) 2007-09-15
WO2003032952A1 (en) 2003-04-24
KR100859358B1 (ko) 2008-09-22
CA2462905A1 (en) 2003-04-24
CN1558752A (zh) 2004-12-29
DK1441700T3 (da) 2007-10-08
IL161193A (en) 2010-05-31
ES2288999T3 (es) 2008-02-01
EP1441700A1 (en) 2004-08-04
EP1441700B1 (en) 2007-08-29
KR20040047906A (ko) 2004-06-05
PT1441700E (pt) 2007-10-29
CN100506234C (zh) 2009-07-01
NO335042B1 (no) 2014-09-01
IL161193A0 (en) 2004-08-31
MXPA04003506A (es) 2004-07-23
NO20042011L (no) 2004-06-30
HK1068282A1 (en) 2005-04-29

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Effective date: 20211015